The aim of this study is to evaluate the effect of Ondansetron on prevention of Ventilator associated pneumonia in ICU. This study design is as a kind of intervention no-blinded randomized clinical trial that perform on 80 patients intubated with an endotracheal tube hospitalized in intensive care units in Shahrekord kashani hospital. Patients will be randomly divided into two groups of 40 people of case and control. Inclusion criteria: patients aged 15-65 years; with the full consent of the patient protector; the patient respiratory support with ventilation; more than 48 hours hospitalization in the ICU. Exclusion criteria: patients out of the age range 15-65 years; patients with suspected pulmonary health is arrival; the lack of satisfaction of the patient protector. Intervention: to case group is injected 4 milligram Ondansetron and to case group is injected 4 milligram placebo, each one twice daily for five days, then primary outcome include the rate of Ventilator associated pneumonia and secondary outcomes include fever, leukopenia, purulent sputum, cough and shortness of breath will be analyzed daily for 5 days in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201406156480N6
Registration date:2015-10-06, 1394/07/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-10-06, 1394/07/14
Registrant information
Name
Mohammad Taghi Moradi
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1334 9509
Email address
mtmoradi@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahrekord University of Medical Sciences
Expected recruitment start date
2011-03-20, 1389/12/29
Expected recruitment end date
2012-03-19, 1390/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Ondansetron compared with placebo on prevention of Ventilator associated pneumonia in ICU
Public title
The effect of Ondansetron on prevention of Ventilator associated pneumonia in ICU
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients aged 15-65 years; with the full consent of the patient protector; the patient respiratory support with ventilation; more than 48 hours hospitalization in the ICU
Exclusion criteria: patients out of the age range 15-65 years; patients with suspected pulmonary health is arrival; the lack of satisfaction of the patient protector.
Age
From 15 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
In this study sampling method is a table of random numbers.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahrekord University of Medical Sciences
Street address
Shahrekord University of Medical Sciences, Rahmatie, Shahrekord
City
shahrekord
Postal code
8815713471
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
901033
Health conditions studied
1
Description of health condition studied
Pneumonia
ICD-10 code
J17
ICD-10 code description
Pneumonia in diseases classified elsewhere
Primary outcomes
1
Description
Ventilator associated pneumonia
Timepoint
Before and 5 days after the intervention, once a day
Method of measurement
Chek list (based on clinical symptoms and laboratory)
Secondary outcomes
1
Description
Fever over 38 ° C without any known other infectious focus
Timepoint
Before and 5 days after the intervention, once a day
Method of measurement
Clinical signs
2
Description
Leukopenia
Timepoint
Before and 5 days after the intervention, once a day
Method of measurement
Lab data
3
Description
Purulent sputum
Timepoint
Before and 5 days after the intervention, once a day
Method of measurement
Clinical signs
4
Description
Create new cough or worsening cough previous or shortness of breath or increased respiratory rate
Timepoint
Before and 5 days after the intervention, once a day
Method of measurement
Clinical signs
5
Description
Disruption of blood gases
Timepoint
Before and 5 days after the intervention, once a day
Method of measurement
Lab data
Intervention groups
1
Description
Intervention group: injection 4 milligram Ondansetron twice a day for 5
Category
Prevention
2
Description
Control group: injection 4 milligram placebo twice a day for 5 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahrekord kashani hospital
Full name of responsible person
Dr Hossein Madineh
Street address
Kashani hospital, Parastar Street, Shahrekord
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, shahrekord University of Medical Sciences
Full name of responsible person
Dr Mahmoud Mobasheri
Street address
Vice Chancellor for research, Shahrekord University of Medical Sciences, Kashani Street, Shahrekord
City
shahrekord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, shahrekord University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Dr Hossein Madineh
Position
Anesthesiologist
Other areas of specialty/work
Street address
Shahrekord University of Medical Sciences, Rahmatie, Shahrekord
City
Shahrekord
Postal code
Phone
+98 38 3333 0061
Fax
Email
hosseinmadineh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Dr Hossein Madineh
Position
Anesthesiologist
Other areas of specialty/work
Street address
Shahrekord University of Medical Sciences, Rahmatie, Shahrekord
City
Shahrekord
Postal code
Phone
+98 38 3333 0061
Fax
Email
hosseinmadineh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Dr Hossein Madineh
Position
Anesthesiologist
Other areas of specialty/work
Street address
Shahrekord University of Medical Sciences, Rahmatie, Shahrekord
City
Shahrekord
Postal code
Phone
+98 38 3333 0061
Fax
Email
hosseinmadineh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)